Cambrex QA Technical Advisor in Charles City, Iowa
QA Technical Advisor
If you’re looking for a dynamic career move, look no further.
Cambrex is an innovative life sciences company with a refreshingly human approach. Driven by passion, our pharmaceutical products, expertise and technologies are accelerating small molecule therapeutics into the market to help businesses grow.
We are tried and trusted across branded and generic API markets
We put all of our energy and experience into being a partner of choice
Our people are the experts customers enjoy working with
Headquartered in East Rutherford, New Jersey, Cambrex supports its customers worldwide with a network of API R&D and cGMP manufacturing facilities across the US and Europe.
As the number one contract manufacturing organization (CMO) for small molecule APIs in the USA and one of the fastest growing CMOs in Europe, we are leading the way in terms of small molecule API development and manufacturing. Not only that, our passionate people love what they do and always go the extra mile for our customers.
Create a better world at Cambrex
Known for our manufacturing excellence, experience and innovative science, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve quality of life for our customers’ patients across the world.
Cambrex Charles City, Inc. is a subsidiary of Cambrex and develops and manufactures active pharmaceutical ingredients, fine chemicals and pharmaceutical intermediates for a wide range of applications.
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Cambrex Charles City, Inc. is seeking a QA Tech Advisor at our manufacturing plant in Charles City, Iowa who shares the values and principles that characterize who we are and how we work. It's time to join our world-class team, if the following
The QA Tech Advisor will report to the Manager of Quality Assurance.
Accountabilities and Responsibilities:
Key Quality Assurance customer support person to answer, address and/or compile relevant data to support Cambrex Charles City, Inc. (CCC) products through customer requests through, but not limited to:-Review of customers specifications -Description of process chemistry -Description of impurity profiles -Providing Standard statements of compliance
Review and approval of CCC technical documents
Serve as a liaison with new and existing customers concerning regulatory filings (i.e. coordinating issuance of CEPs, preparation and submission of Letters of Authorization, coordinate filings of EDMF/CDMF with MAA, communicate changes and proposed changes, coordinate responses to customer inquiries).
Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impacts.
Review of data/records received from R&D, manufacturing, analytical, supply chain and Quality Assurance departments for corresponding with customers for regulatory support.
+ B. Pharm./M. Pharm. or M.Sc../Ph. D. in Chemistry
+ 5-10 years of relevant experience
- Ability to maintain written and oral communication in English required
Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' Post offer physical and drug screen are required. Interested candidates should submit a resume and cover letter with salary requirements to Human Resources, Cambrex Charles City, Inc.: online: www.cambrex.com. Thank you for your interest in Cambrex Charles City!
Agencies should not forward resumes to Cambrex through this source. Please visit www.cambrex.com to become a preferred vendor and submit a Request for Proposal (RFP) online for consideration. Cambrex will not be responsible for any fees arising from the use of resumes through this source.
Key Words:PurchasingManufacturingGeneral office skillsInvoicing
Charles City, Iowa, United States